ADHD Drugs: Children At Risk – Safety Signals Reported

by Gabriel F Zambrano

As any parent knows, you love your child unconditionally even before they enter the world. Life becomes even more complex as they grow and develop. The diagnosis of any illness adds another layer of complexity and challenges for parents. This post will focus on the controversial and growing diagnosis of ADHD (Attention Deficit Hyperactivity Disorder), also known as “ADD” in children and how a new generation of children are being exposed to risks from popular drugs used to treat the diagnosis. Information on the complex diagnosis of ADHD or ADD from the National Institute of Mental Health (NIH) is available here and beyond the scope of the discussion below. Suffice it to say it is a controversial diagnosis, hot button issue with many and a diagnosis that continues to grow as Blockbuster drugs are invented and marketed to address the condition. Again, diagnosis and treatment are beyond the scope of the discussion that follows.

Questions of safety and efficacy (effectiveness) and balancing risks posed present an ever present balancing act that patient and physician often weigh together. In the instance of children, what hangs in the balance becomes even more compelling and the decision is often fueled by factors that complicate decision making for parents and treaters.

What is ADHD or ADD?

ADHD (Attention Deficit Hyperactivity Disorder) is reportedly one of the most common childhood disorders in contemporary society. It is estimated to affect 4.1% of American adults age 18 years and older and 9% of American Children age 13-18.The NIH estimates that Boys are 4 times at higher risk than girls of being diagnosed. Symptoms of ADHD or ADD include symptoms of inattention, hyperactivity and impulsivity that are further explored here by the NIH.

What drugs treat ADHD or ADD?

ADHD or ADD is treated with by a combining education of parents, psychotherapy and a medication regimen in certain cases. The most common types of medications are called “stimulants” and come in multiple variations. They are so common and in demand because of the diagnosis that the following chart identifies available stimulants for use in children as early as age 3


There is reason to consider the safety and efficacy of these drugs carefully as further discussed below.

IMSP – Special Report on Children

Adverse Drug Events in Children Under Age 18

In January 2014, the Institute for Safe Medication Practices (ISMP) released a “Special Report on Children“. The ISMP publishes QuarterWatch as a public service. QuarterWatch “monitors the safety of prescription drugs through analysis of adverse drug events” reported to the U.S. Food & Drug Administration (FDA) by consumers and health care professionals, either directly to the agency or through drug manufacturers. The FDA release computer excerpts for research use on a quarterly basis and these case reports are analyzed by the ISMP QuarterWatch.


In analyzing data from, for 2008-2012, 15 (fifteen) drugs accounted for 41% (forty one percent) of recent serious adverse events in children reported to the FDA. The illustration below from QuarterWatch lists all 15. Notably, 3 (three) of these drugs are approved for the treatment of ADHD or ADD and the most frequent adverse events included “sudden death” and “suicidal ideation”.

Two stimulants used to treat ADHD/ADD are listed at #6 CONCERTA (Methlyphenidate) and #8 VYVANSE (Lisdexamfetamine) in conjunction with the anti-depressant like #12 STRATTERA (Atomoxetine). CONCERTA not as widely known as RITALIN but in the same family. According to IMSP QuarterWatch, these drugs and the adverse reports were notable for suicidal behaviors, aggression, hallucinations and other manifestations of psychosis. Cardiac arrest was associated with #6 CONCERTA (Methylphenidate) or RITALIN. While all three were also associated with arrested growth or weight loss. ISMP QuarterWatch concluded that the FDA has already required warnings for hallucinations and other psychotic symptoms, but that is should investigate the need for warnings about the more frequent reports of suicidal behaviors.

The adverse event reporting system is a self-reporting system and arguably in need of modernization to improve the frequency and quality of reporting. A January 2015 ISMP QuarterWatch actually provides a critique of key drug safety reporting systems in the United States.




The increase of ADHD/ADD being diagnosed is statistically settled. A scientific debate continues over “cause and effect” that remains unsettled and fuels advocates with agendas. The ever growing demand for stimulants appears to be endless. In fact, in “FDA Finds Short Supply of Attention Deficit Drugs“, Gardiner Harris, explored how demand was out growing supply for the drugs and their abuse. In a related NYTimes Opinion, L. Alan Sroufe, Professor Emeritus of Psychology at the University of Minnesota’s Institute of Child Development, explored “Ritalin Gone Wrong” and questions decade of reasoning fueling the use of stimulants. During March/April 2014, ESQUIRE explored the complexity of diagnosis and treatment for ADHD/ADD as a growing epidemic among boys in “The Drugging of the American Boy” requiring scrutiny.


Children are at risk and the most rigorous of debates and studies should be undertaken to safeguard future generations. The reports observed and discussed above are most likely grossly underreported as the adverse event system relies upon self-reporting or reporting by physicians. There are no mandatory requirements for the reporting of adverse events and most events are likely under reported or not properly identified as being linked to a drug. The potential fear of stigma from the diagnosis and cure are likely a deterrent to parents and physicians alike under already difficult and complicated circumstances.